Medical adhesive solvent composition

ABSTRACT

A solvent composition is provided which will efficiently remove medical adhesives, particularly adhesives containing silicone resins, from skin and simultaneously replace body oils, and prepare the skin to receive subsequent applications of the adhesive. The solvent composition comprises a major effective amount of a liquid aliphatic hydrocarbon solvent fraction, preferably a C8 to C11 aliphatic hydrocarbon fraction, a minor effective skin conditioning amount (generally comprising at least about 2 weight percent) of silicone fluid, and preferably, a minor effective amount of a flash point suppressant for the liquid aliphatic hydrocarbon fraction.

United States Patent [1 1 3,789,118 Broerman 1 Jan. 29, 1974 MEDICALADHESIVE SOLVENT Primary Examiner-Shep K. Rose COMPOSITION [76]Inventor: Arthur B. Broerman, 5901 Baylor,

Bartlesville, Okla. 74003 [22] Filed: July 16, 1971 [2]] Appl. No.:163,498

[52] US. Cl 424/45, 252/364, 424/78, 424/184 [51] Int. Cl. B011 1/00,C23g 5/00, A6lk 9/00 [58] Field of Search 252/364; 424/184, 78, 45

[56] References Cited UNITED STATES PATENTS 2,681,878 6/1954 Kauppi424/184 2,727,846 l2/l955 Talbot 424/l84 3,298,919 H1967 Bishop et al.424/47 3,470,292 9/1969 Marschner 424/47 FirmRichards, Harris &

[57] ABSTRACT A solvent composition is provided which will efficientlyremove medical adhesives, particularly adhesives containing siliconeresins, from skin and simultaneously replace body oils, and prepare theskin to receive subsequent applications of the adhesive The solventcomposition comprises a major effective amount of a liquid aliphatichydrocarbon solvent fraction, preferably a C to C aliphatic hydrocarbonfraction, a minor efiective skin conditioning amount (generallycomprising at least about 2 weight percent) of silicone fluid, andpreferably, a minor effective amount of a flash point suppressant forthe liquid aliphatic hydrocarbon fraction.

4 Claims, No Drawings 1 MEDICAL ADHESIVE SOLVENT COMPOSITION Thisinvention relates to solvents. In another aspect, this invention relatesto a novel medical solvent and skin preparation composition. In stillanother aspect, this invention relates to a novel method of applying andremoving prosthetic devices and the like from the skin.

Various medical prosthetic devices and body appliances are utilizedwhich are affixed to the human body with a medical adhesive composition.Widely utilized body appliances include cosmetic body appliances forcovering scars resulting from severe injuries, for example. Theseappliances are generally made of silicone rubber and utilize a siliconeresin medical adhesive to affix them to the body surface. Prostheticdevices in clude male urinal devices which are affixed to the body withmedical adhesives.

Thus, such medical prosthetic devices and body appliances must, when inuse, be securely affixed to the skin of the patient. However, formedicinal and hygienic reasons, such devices and appliances must beperiodically removed from the skin and then later reapplied thereto.

Since the conventional medical adhesive compositions will tenaceouslyadhere to both the prosthetic device, or body appliance and the skin, itis necessary to apply a solvent for the adhesive in order to remove thedevice or appliance from the skin. For example, when such device orappliance is made of silicone rubber and a silicone resin is utilized asthe medical adhesive, it is conventional to use V.M. & P. naphthas orfluorocarbons as solvents therefor. The V.M. & P. naphthas are veryharsh and tend to chap and blister as well as dry out the living tissueto which they are applied. The liquid fluorocarbons are expensive, andalso tend to chap and dry out the skin. The deleterious effects on theskin which are imparted by the conventional solvents result (1) from theirritating effect the chemicals have upon the skin, and (2) because thesolvents actually leach essential body fats and oils from the skin andleave them dry, chapped and scaly.

Therefore, one object of this invention is to provide a solventcomposition which will effectively remove conventional medical adhesivesfrom skin, but is nondeleterious to the human body.

A further object of this invention is to provide a novel solventcomposition which will effectively remove medical adhesives from skinwhile simultaneously treating the skin to prevent drying and chapping.

A further object of this invention is to provide a novel solventcomposition which will effectively remove silicone resin, medicaladhesives and simultaneously treat the skin to prevent drying andchapping while preparing the skin to tenaceously receive a subsequentcoating of silicone resin adhesive.

According to the invention, a solvent composition is provided which isparticularly suitable for removing medical adhesives from the skin, andcomprises a major effective amount of a liquid aliphatic hydrocarbonfraction as solvent, and a minor effective skin conditioning amount ofasilicone fluid. In addition, the solvent composition preferably containsan effective proportion of a flash point suppressant for the liquidaliphatic hydro carbons.

According to a preferred embodiment of this invention, the medicaladhesive solvent composition is pro vided which comprises a majoreffective amount of an aliphatic hydrocarbon fraction which includesfrom about 30 to about weight percent of a fraction consistingessentially of aliphatic C and Cu hydrocarbons and from about 30 to 70weight percent of a fraction consisting essentially of aliphatic C and CH hydrocarbons; from about 15 to about 25 weight percent of flash pointsuppressant; and at least about 2 weight percent of a silicone fluid. Aparticularly effective combination includes equal parts of the aliphaticC -C fraction and the C -C fraction.

The composition of the subject invention can be utilized to removeconventional medical adhesives from the skin, and from other surfacessuch as the skin contacting surfaces of prosthetic devices and bodyappliances. It is herein noted that the term body appliance as used inthe scope of this invention includes any prosthetic device or bodyappliance which is attached to the body by medical adhesivecompositions.

Furthermore, the composition of the subject invention is particularlyeffective for both removing silicone resin medical adhesive compositionsfrom the skin, and preparing the skin for applications of such siliconeresin medical adhesive compositions. The liquid aliphatic hydrocarbonsolvent fraction is non-toxic and is not readily absorbed through humanskin but yet functions to dissolve conventional medical adhesivecompositions such as silicone resin adhesive compositions. In addition,the silicone fluid component functions not only to replace body fats andoils which have been leached by the solvent component, but alsofunctions to prepare the skin to tenaceously receive a subsequentapplication of silicone resin.

The liquid aliphatic hydrocarbon fraction used in the solventcomposition of this invention can have aliphatic components therewithin,containing from about 6 to about 15 carbon atoms. To avoid volatilityextremes and yet utilize extremely effective solvent components for amedical adhesive, it is generaliy preferred that the liquid aliphatichydrocarbons consist essentially of from C to C straight and/or branchedchain molecules, While some unsaturation can be present in themolecules, the preferred fractions contain a majority of paraffmiccomponents. The percentage of the individual components can be varied asdesired within the scope of this invention. For example, the aliphaticsolvent fraction can comprise a majority of C s, C s, C s, or C s orvarious combinations thereof.

The most preferred liquid aliphatic hydrocarbon fraction which can beused in the solvent composition of this invention includes from about 30to 70 weight percent of a first fraction of aliphatic C,;C (C s and- /orC s) hydrocarbons combined with from about 30 to about 70 weight percentof a second fraction of aliphatic (Z -C (C s and/or C s} hydrocarbons.This fraction in combination with the other ingredients of the subjectcomposition has been found to be particularly effective for removingmedical adhesives, such as silicone resins and yet not impartdeleterious effects to the skin. Generally, said first fraction willhave a boiling range at 760 mm Hg within the range of from 200-260F, andsaid second fraction will have a boiling range at 760 mm Hg within therange of from 300 to 350 F.

The silicone fluid which can be used in the scope of this inventionincludes any of the liquid organosiloxane polymers which arenondeleterious to human skin, for

example, the methyl or phenyl polysiloxanes. The organisiloxane polymerswhich can be used in the composition of this invention have a wide rangeof viscosities of less than 1 (about 0.65) to several thousandcentistokes. It is generally preferable to utilize an organosi loxanewhich has a viscosity in the range of from about to about 100centistokes. The silicone fluid is generally contained within thecomposition of the subject invention in amounts of at least about 2weight percent thereof, and is most preferably contained in thecomposition of this invention within the range of about 2 to about 4weight percent. Greater amounts (for example l0 weight percent) can beused if desired; however, it has been found that a silicone fluidcontent of from 2 to 4 weight percent is sufficient for most uses.

As described above, the silicone fluid functions in cooperation with theliquid aliphatic hydrocarbon component in the solvent composition ofthis invention. When the solvent composition of the subject invention isapplied to an adhesive coating on animal skin, and particularly humanskin, the silicone fluid readily coats the living tissue and functionsto immediately replace body fats and oils which are leached therefrom bythe action of the solvent. Thus, the silicone fluid efficiently coatsthe skin and combines with the skin to thereby prevent chapping andirritation clue to loss of body fats and oils. This residue or coatingof the silicone resin upon the skin which results from the applicationof the solvent composition of this invention thereto, tenaceouslyadheres to the skin and will not be removed by the application of mildsoaps or detergents when removing the solvent-adhesive residue or whenwashing the skin after the solvent-adhesive residue has been wiped away.

The residue or coating which remains on the skin after application ofthe solvent composition of this invention imparts a special affinity tothe skin for subsequent amounts of the silicone resin. Thus, it has beenfound that when the solvent composition of the subject invention is usedto remove the silicone resin, subsequent applications of the siliconeresin when reapplying the prosthetic device or body applicance will bereceived more uniformly on the skin and form a more efficient sealbetween the skin and the device or appliance than when conventionalsolvents are initially utilized.

In addition to the liquid aliphatic hydrocarbons and the silicone fluidcomponents of the subject invention, a flash point suppressant orretarder is preferably added thereto. Any suitable flash pointsuppressant which is nondeleterious to the human body can be used in thescope of this invention. The preferred flash point suppressants are thehalogenated lower alkyl hydrocarbons (about 1 to about 5 carbon atoms),such as for example, trichloroethane, tetrachlorodifluoroethane,trichloromonofluoromethane, trichlorotrifluoroethane, mixtures thereofand the like. The flash point suppressant is added to the solventcomposition of this invention generally in amounts ranging from about 15weight percent to about 25 weight percent thereof, depending upon thevolatility of the particular liquid aliphatic hydrocarbon fraction usedin said composition. Most preferably, the flash point suppressant isadded in amounts of from about 18 to about 20 weight percent of thetotal composition. Generally, the flashpoint of the resultingcomposition then will be no less than F as detennined by ASTM D-56, andwill generally be at least lOO F or more.

The components of the solvent composition of the subject invention canbe admixed in any suitable manner. For example, it is convenient to addthe silicone fluid and the flash point suppressant to the liquidaliphatic hydrocarbon and mix until a generally uniform composition isobtained.

The following example is given to further illustrate the scope of thisinvention and is not intended to limit the scope thereof:

EXAMPLE A solvent composition of the subject invention was made byadmixing 40 parts by weight of a first liquid aliphatic hydrocarbonmixture consisting essentially of C and C hydrocarbons (a mixture soldunder the trademark of SOLTROL 10 by Phillips Petroleum Co.) and haVingthe characteristics as set forth in Table l below, with 40 parts byweight of a second liquid aliphatic hydrocarbon fraction consistingessentially of C and C hydrocarbons (a mixture sold under the trademarkof SOLTROL lOO by Phillips Petroleum Co. and having the characteristicsas set forth in Table ll below.

TABLE I Property Typicnt Test Mcthutl Distillation, rec, "F at 760 mmASI'M D-Xh 202 209 2 l 7 227 245 0.01133 neutral l negative 28 2 noneAS'IM AS'IM ASTM ASTM ASTM AST M ASTM AS I'M ASTM AS'lM ASTM ASTM TABLEll Property Typical Test Method Distillation, evap, "F at 760 mm ASTMD-R DP 343 API Gravity at 60F 58.7 ASTM D487 Specific Gravity, fvtlfbtPF0.744 ASTM D-l298 20MC 0.740 Wcstphal Balance Density at 60F, lb/gul 619ASTM D-l 250 Flash Point, TCT, Fv I ASTM D-56 Color Sayholt +30 ASTMD-l56 Corrosion. Copper Strip, 3 hrs at 2l2F l ASTM D-l30 Acidity ofDistillation Residue neutral ASTM D4093 Aniline Point, "F 179 ASTMD-l0l2 Next. 18 parts by weight by trichloroethane and 2 parts by weightof silicone fluid (a silicone fluid sold under the trademark of DC 200,by Dow-Corning and having from to I00 centistokes viscosity) was addedto the 80 parts by weight of the liquid aliphatic hydrocarbons to formthe medical solvent composition of the subject invention.

This medical solvent composition was used to remove a medical adhesive(a silicone resin medical adhesive sold under the trademark of MEDICALADHE- SlVE B" by Dow-Corning Medical Products Division). The medicaladhesive was used in attaching to a human male a prosthetic device forthe handling of urinary incontinence. This prosthetic device basicallycomprised a knit sheath impreganted with silicone rubher and is fullydisclosed in my copending patent application Ser. No. 008,819, filedFeb. 5, 197]. The solvent was used to remove the device numerous timesover a period of several months. In each instance, the solventcomposition was applied during the removal operation and thereafter theskin area which was contacted by the solvent composition was washed withmild soap and water and the solvent residue containing the dissolvedadhesive was flushed away. A layer of silicone fluid remained on theskin. When it was desired to reapply the prosthetic device, the siliconeresin medical adhesive was applied over the skin which carried thesilicone fluid coating, and the prosthetic device then applied thereto.During this several months period, no skin irritation whatsoever wasobserved and furthermore, the silicone resin adhesive was found to veryeffectively adhere to the treated area in an improved manner than whenconventional solvents such as V.M. & P. naphthas are used to remove themedical adhesive.

While this invention has been described in relation to its preferredembodiments, it is to be understood that various modifications will beapparent to one skilled in the art from a reading of this specification,and it is intended to cover such modifications as fall within the scopeof the appended claims.

I claim:

1. A skin conditioning medical adhesive solvent and skin preparationcomposition which consists essentially of:

a. about 2 to about l0 weight percent of liquid or ganosiloxane polymereffective to replace body fats and oils leached from the skin by solventaction;

b. about 5 to about 25 weight percent of a halogenated lower alkylhydrocarbon flashpoint suppressant selected from the group consisting oftrichloroethane, tetrachlorodifluoroethane, trichloromonofluoromethane,trichlorotrifluoroethane, and mixtures thereof; and

c. the balance of said composition which consists essentially of asolvent of from about 30 to about weight percent ofa mixture of C Caliphatic hydrocarbons and from about 30 to about 70 weight percent of amixture of C C aliphatic hydrocarbons;

said solvent not imparting deleterious results to the skin, saidcomposition forming a more efficient seal with silicone resin medicaladhesive between the skin and a prosthetic device or appliance uponreapplication thereof.

2. The composition of claim 1 wherein said flashpoint suppressant istrichloroethane.

3. The composition of claim 1 wherein said flashpoint suppressant istrichlorotrifluoroethane.

4. A medical adhesive solvent and skin preparation composition whichconsists essentially of parts by weight of a solvent constituent whichincludes a liquid aliphatic hydrocarbon fraction which consistsessentially of from about 30 to about 70 weight percent of a mixture ofC C aliphatic hydrocarbons and from about 30 to about 70 weight percentof a mixture of C C aliphatic hydrocarbons, 18 parts by weight of ahalogenated lower alkyl hydrocarbon selected from the group consistingof trichloroethane, tetrachlorodifluoroethane,trichloromonofluoromethane, trichlorotrifluoroethane, and mixturesthereof; and 2 parts by weight of a liquid organosiloxane polymer.

2. The composition of claim 1 wherein said flashpoint suppressant istrichloroethane.
 3. The composition of claim 1 wherein said flashpointsuppressant is trichlorotrifluoroethane.
 4. A medical adhesive solventand skin preparation composition which consists essentially of 80 partsby weight of a solvent constituent which includes a liquid aliphatichydrocarbon fraction which consists essentially of from about 30 toabout 70 weight percent of a mixture of C8 - C9 aliphatic hydrocarbonsand from about 30 to about 70 weight percent of a mixture of C10 -C11aliphatic hydrocarbons; 18 parts by weight of a halogenated lower alkylhydrocarbon selected from the group consisting of trichloroethane,tetrachlorodifluoroethane, trichloromonofluoromethane,trichlorotrifluoroethane, and mixtures thereof; and 2 parts by weight ofa liquid organosiloxane polymer.